NCT04027920

Brief Summary

A rare case of disastrous delayed postpartum hemorrhage after three days of shenghua decoction treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 2, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 17, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 17, 2019

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

July 12, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 22, 2019

Completed
Last Updated

June 2, 2020

Status Verified

July 1, 2019

Enrollment Period

2 months

First QC Date

July 12, 2019

Last Update Submit

May 31, 2020

Conditions

Keywords

postpartum hemorrhage

Outcome Measures

Primary Outcomes (1)

  • Presence of postpartum hemorrhage or not

    Presence of postpartum hemorrhage or not, following three days of shenghua decoction treatment. The total estimated blood loss was approximately 2000 mL at that time. Her hemoglobin was revealed to be 2.6 g/dL, her hematocrit was 8.5%, and the vaginal bleeding persisted despite medications, so emergency total hysterectomy was performed.

    1 year

Interventions

Three days' shenghua decoction treatment

Eligibility Criteria

Age20 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A postpartum woman with delayed pospartum hemorrhage

You may qualify if:

  • Postpartum hemorrhage after shenghua decoction treatment.

You may not qualify if:

  • Nil

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital

Banqiao District, New Taipei, 22050, Taiwan

Location

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Shenghua Decoction

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPuerperal DisordersUterine HemorrhageHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Department of Obstetrics and Gynecology

Study Record Dates

First Submitted

July 12, 2019

First Posted

July 22, 2019

Study Start

May 2, 2019

Primary Completion

June 17, 2019

Study Completion

June 17, 2019

Last Updated

June 2, 2020

Record last verified: 2019-07

Locations